Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Atlanta District Office|
60 8th St., NE
Atlanta, GA 30309
September 17, 2014
Chris T. Li, CEO/Owner
Well Luck Company, Inc.
104 Harbor Drive
Jersey City, NJ 07305
Dear Mr. Li,
On July 23, 2014 thru August 7, 2014 the U.S. Food & Drug Administration (FDA) conducted an inspection of your food manufacturing and storage facility located at 1585 Market Dr. SE, Atlanta, GA. The FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulations, found in Title 21 of the Code of Federal Regulations Part 110 (21 CFR 110). The violations, which include evidence of active rodent activity, render the products held at your facility adulterated within the meaning of Section 402(a)(4) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 United States Code (U.S.C) § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and pertinent FDA regulations through links on FDA's website at www.fda.gov.
The serious CGMP violations noted during the inspection were outlined on a FORM FDA 483, Inspectional Observations, issued to Mr. Khong H. Khoo, General Manager at the close of the inspection. A copy is enclosed for your review. Those violations include the following:
1. You are not taking effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests as required by 21 CFR 110.35(c).
During our inspection, FDA Investigators collected physical and visual evidence of widespread rodent and insect activity within your facility.
• On July 23rd a live mouse was observed running alongside the Northwest dock area of the warehouse into stacked pallets.
• On July 23rd two live mice were observed stuck to glue from a smeared glue trap located near 2200 bags of Jasmine Rice stored approximately 15 feet from the trash compactor located in dock door number 1.
• On July 23rd a dead mouse was observed on a glue trap inside the cooler adjacent to the cooler entrance door.
• On July 23rd a dead mouse was observed on a glue trap in the picking area along the outside of the freezer on the West wall adjacent to the freezer entrance door.
• On July 23rd a dead mouse was observed on a glue trap in the picking area behind a product storage rack in the middle of Aisle D.
• On July 25th a dead rat was observed in a rodent trap along the Southwest wall of the warehouse storage area adjacent to the Return/Quarantine/Morgue Area.
The physical samples #JNV-752539 & Dl-752541 that were collected during the inspection were analyzed by our laboratory. The analysis of sample #TNV-752539 confirmed the material collected from various locations within your facility included rodent excreta pellets. The analysis of this sample also confirmed the bag cutting that was collected contained a rodent gnaw hole with rat/mouse incisor marks as well as rat/mouse hair. Analysis of sample #DI-752541 revealed the bag cuttings taken from the sampled lot of whole wheat flour contained rodent urine. The visual observations and the analytical results for these samples confirm the presence of active rodent activity within your facility.
On July 25th the FDA Investigators observed live roach-like insects too numerous to count along the East wall of the fortune cookie processing room directly behind the ice machine and adjacent to the (b)(4) stand mixers in use during production.
We acknowledge that the Investigators confirmed on July 25th that your firm had cleaned the Quarantine/Return/Morgue area of the warehouse to remove the rodent excreta pellets. We also acknowledge that during the inspection on August 6th Mr. Khoo voluntarily destroyed 47 bags of rodent defiled wheat flour that were sampled under sample #DI-752541.
2. You have failed to properly store equipment, remove litter and waste, or cut weeds or grass that may constitute an attractant, breeding place, or harborage area for pests within the immediate vicinity of the plant buildings or structures as required by 21 CFR 110.20(a)(1).
On July 23rd the FDA Investigators observed an accumulation of spilled food, opened and damaged boxes and pallets that were on the warehouse cooler and freezer floors. On July 24th the Investigators also observed food products (rice & flour) spilled onto the warehouse floor beneath and between palletized products throughout several aisles. In addition on July 24th, they observed a large bin of discarded fortune cookies that had been left uncovered overnight adjacent to the trash compactor. The trash compactor located in dock door 1 was observed to have an abundant amount of sludge and apparent food-like material adhered to it. These conditions in warehouse areas serve as food sources and attractants for rodents and other pests.
On July 23rd the FDA Investigators observed large machinery, equipment and tools stored ceiling high in racks along the Southwest wall of the warehouse storage area in close proximity to the fortune cookie packaging room door. They also observed unused large machinery, equipment, tools and finished packing materials stored in the aisles of the West warehouse storage area in close proximity to the processing room door. On July 24th, they observed tall grass and weeds around the perimeter of the building as well as discarded tires and pieces of metal. These conditions create areas both in and around your facility where rodents or other pests may find harborage and breed.
We acknowledge that during the inspection on July 30th, the Investigators observed that your firm had cut the tall grass and weeds around the perimeter of the building, and the excess equipment, tools and large machinery had been staged outside the facility and were awaiting removal.
3. You have failed to maintain buildings, fixtures and physical facilities in repair sufficient to prevent food from becoming adulterated as required by 21 CFR 110.35(a).
During the inspection on July 24th the FDA Investigators observed:
• An approximate two inch gap around the metal framing around the trash compactor
• An approximate two inch gap in the freight entrance door located on the South wall of the warehouse storage area
• An approximate two inch gap in working dock doors 2-19 (18 doors total) located on the Northwest and Northeast sides ofthe warehouse storage areas
• An approximate three inch gap in the cooler and freezer doors because the doors do not close properly
• An approximate one inch long and one-half inch wide hole observed on the Southeast wall approximately fifteen feet from the canned food storage area
• An approximate five inch wide hole in diameter on the Northwest outside wall of the building approximately six feet West of the outdoor portion of the trash compactor
Your failure to adequately maintain your facility has created multiple access areas for rodents to enter the building from the outside.
We acknowledge that during the inspection on August 6th, the Investigators observed that your firm had repaired a hole which they had previously observed in the Southeast wall by filling it with cement.
4. You have failed to construct your plant in such a manner that will prevent drip and condensate from contaminating food as required by 21 CFR 110.20(b)(4).
On July 23rd FDA Investigators observed frozen condensate and ice build-up on a rack inside and above the freezer entrance door and on ceiling light fixtures. The ceiling air handling unit was also observed dripping condensate onto popsicles, wantons, dumplings and dim sum food products stored directly below along several aisles.
We acknowledge that on July 29th the Investigators observed that your firm had removed the condensate and ice build-up that was previously observed on the overhead light fixtures and air handling unit in the warehouse freezer.
5. You have failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7).
During the inspection on July 23rd the FDA Investigators observed doors in food manufacturing areas of the facility to be completely open to the outside environment because a door was left open. One of the open doors was located in the fortune cookie processing room and another was located in the sesame oil processing room. These open doors provide access for animals, rodents, pests, and environmental contaminants to enter into food manufacturing areas and potentially contaminate food.
6. You have not taken proper precautions to protect food, food-contact packaging materials from contamination with filth and extraneous material due to deficiencies in the plant construction and design as required by 21 CFR 110.20(b)(2).
During the inspection on July 23rd the FDA Investigators observed there was no barrier between the North side of the fortune cookie packing room and the West side of the warehouse storage area where the trash compactor is located and where rodent activity was observed. Unpackaged fortune cookies were observed sitting directly on the floor of the fortune cookie packaging room. Without any barrier between the warehouse and the fortune cookie packaging room, rodents in the warehouse area have direct access into the food processing areas of the facility where they may contaminate the food, food packaging materials, and food processing equipment.
We acknowledge that on July 30th, the Investigators observed that your firm had installed a sliding door on the entrance to the fortune cookie packaging room.
No response has been received from you or your firm to date addressing what corrective actions will be taken to correct the deficiencies at your firm and listed on the FORM FDA 483. Neither this letter nor the FORM FDA 483 is intended to be an all-inclusive statement of the violations that exist at your firm. You are responsible for ensuring that your firm is operating in compliance with all the requirements of the Act and pertinent FDA regulations. You should take prompt actions to correct the violations cited in this letter. Failure to promptly and adequately correct these violations may result in FDA initiation of regulatory actions, including but not limited to, seizure of your products or injunction.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determining whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31 (a)(2)(B)]. For a domestic facility,
FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility.
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or plan to take to correct the current violations and prevent similar ones. Include the timeframe within which the corrections will be completed and documentation that will effectively assist us in evaluating the adequacy of the corrections, such as photographs. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the timeframe within which you will complete the corrections.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Janice L. King, Compliance Officer, at the address noted in the letterhead. If you have any questions, please contact Mrs. King at 843-746-2990, Ext. 18 or write her at the noted address.
Ingrid A. Zambrana
CC: Khong H. Khoo, General Manager
Chiu-Hung Tam, Factory Manager/Master Mechanic
Well Luck Company, Inc.
1585 Market Dr. SE
Atlanta, GA 30316-4718